Consumer Hero vs. Big Pharma – Who Wins?

October 13, 2009

By Terry Smiljanich:

For more than 20 years Dr. Dennis Mangano, a California anesthesiologist, has waged a lone battle against major drug manufacturers. His major weapon was a unique patient data base he compiled involving thousands of surgery patients from around the world. Thanks to his tireless efforts, unsafe drugs have been taken off the market.

But Dr. Magnano’s good work took a major hit when Pfizer, one of the country’s biggest drug companies, secretly obtained his data base from a traitorous employee. The doctor was forced to sue the company for justice. At the end of a jury trial, Dr. Mangano won and Pfiser suffered a $58 million judgment against it. Happy ending? Read on.

Back in the 80’s, Dr. Mangano became concerned over the high incidence of ischemic (heart) attacks following surgery. After compiling his unique data base from hospitals around the world, Dr. Mangano started the Ischemia Research and Education Foundation (IREF) and began independent studies of drugs on the market and their potential effect on post-surgery heart attacks.

Since the IREF data base was so valuable in evaluating such health problems, it sold access to its data to drug companies with one important requirement – that Dr. Mangano and his organization reserved the right to review any safety studies and publish the results. His goal was to prevent drug companies from hiding any negative results.

Trasylol Deaths

He spent years studying Trasylol, a Bayer drug approved by the FDA for reducing surgery-related blood loss. He concluded that Trasylol actually increased the risk of heart attack and renal failure, and the respected New England Journal of Medicine published his paper concluding that cheaper $11 drugs were safer and more effective than the expensive $1,400 Trasylol.

An FDA panel considered his evidence, and the counter evidence produced by Bayer, and sided with Bayer. Only days later, however, a researcher called the FDA and revealed that Bayer’s own internal studies matched that of Dr. Mangano! Oops. Bayer profusely apologized, and called its failure to mention this at the FDA hearings as a negligent mistake.

Can you even imagine that the FDA let Bayer get away with this absolutely incredible excuse? The FDA finally took Trasylol off the market, but not before some 22,000 Trasylol-related deaths had occurred.

Pfizer and Bextra

Pfizer turned to the IREF in 1999 and paid it $4 million for use of a limited portion of its data in evaluating its new drug Bextra in order to obtain FDA approval. Unfortunately, the study concluded that Bextra’s side effects were dangerous. Despite Dr. Mangano’s paper outlining such problems, the FDA approved Bextra in 2001.

Dr. Mangano offered Pfizer use of an even larger data base, but Pfizer refused (no need to wonder why). Then, in 2004, Dr. Mangano discovered that an employee of IREF had been secretly giving access to the IREF data base to Pfizer. He filed a lawsuit against Pfizer alleging that Pfizer and his former employee had stolen his data, data he said cost him more than $70 million to accumulate.

Pfizer filed the usual post-trial motions, asking the judge to throw out the jury verdict. In July of this year, Judge Gregory H. Ward did exactly that. He concluded, based on his own evaluation of the evidence and disregarding the jury’s opinion, that the IREF employee had “acted without the knowledge and consent of Pfizer.” Judge Ward granted Pfizer a new trial.

A multi-year litigation against a major drug company like Pfizer (with $44 billion in sales in 2008), with a six week trial thrown in, is expensive. The cost of the litigation caused the IREF to be reduced from 80 employees to just 3, and it is now heavily in debt.

Dr. Mangano, with four young children at home, says that he cannot afford another endless round of battle against Pfizer and its legions of attorneys backed by buckets of money. As for his future, he says: “Once you sue a pharmaceutical company, and you go on 60 Minutes as the whistle blower who cost Bayer Trasylol sales, you’re persona non grata,” he said. “No one wants to do business with you.”

And Bextra? It’s finally been removed from the market by the FDA. This year Pfizer agreed to pay a record $2.3 billion to the government for violations of FDA laws, and a Pfizer subsidiary actually pleaded guilty to a criminal charge related to Bextra.

Is Pfizer crying in remorse? Hardly. It put the IREF out of business, and although it paid $2.3 in the government settlement, it posted Bextra sales of almost $2.5 billion in the past three years. Now, Pfizer is a major player at the table involving what to do to reform our health care system. Makes you feel real good inside, doesn’t it?

Whistleblower Connection

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If you have specific evidence a company is defrauding the government, contact the James Hoyer Law Firm. As a whistleblower, you can file a legal action in the government’s name to recover money for taxpayers.